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Wednesday, February 09, 2022 2:15:24 PM
https://www.benzinga.com/general/biotech/22/02/25511786/gamida-cell-shares-surge-on-rolling-omidubicel-marketing-application-in-us?utm_campaign=partner_feed&utm_source=TechInvestorNews&utm_medium=partner_feed&utm_content=site
by Vandana Singh
February 9, 2022 12:54 PM | 1 min read
GMDA has initiated the Biologics License Application (BLA) rolling submission process with the FDA for omidubicel, in patients with blood cancers needing stem cell transplant.
The company remains on track to complete the BLA submission in Q2 of 2022.
Omidubicel has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant.
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